Document Type
Protocol
Publication Date
3-1-2024
Abstract
Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety.
Recommended Citation
Lee, Ian Y.; Hanft, Simon; Schulder, Michael; Judy, Kevin D.; Wong, Eric T.; Elder, J. Bradley; Evans, Linton T.; Zuccarello, Mario; Wu, Julian; Aulakh, Sonikpreet; Agarwal, Vijay; Ramakrishna, Rohan; Gill, Brian J.; Quiñones-Hinojosa, Alfredo; Brennan, Cameron; Zacharia, Brad E.; Silva Correia, Carlos Eduardo; Diwanji, Madhavi; Pennock, Gregory K.; Scott, Charles; Perez-Olle, Raul; Andrews, David W.; and Boockvar, John A., "Autologous Cell Immunotherapy (IGV-001) with IGF-1R Antisense Oligonucleotide in Newly Diagnosed Glioblastoma Patients" (2024). Department of Neurosurgery Faculty Papers. Paper 228.
https://jdc.jefferson.edu/neurosurgeryfp/228
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
38060340
Language
English
Comments
This article is the author's final published version in Future Oncology, Volume 20, Issue 10, March 2024, Pages 579 - 591.
The published version is available at https://doi.org/10.2217/fon-2023-0702.
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